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Current Medicinal Chemistry 2021The translation of nanomedicines from the lab level into marketed product faces several challenges, including characterization of physicochemical properties,...
The translation of nanomedicines from the lab level into marketed product faces several challenges, including characterization of physicochemical properties, pharmacodynamics, pharmacokinetics, process control, biocompatibility, and nanotoxicity, scaling-up as well as reproducibility. The challenges of nanomedicine development are in connection with the different requirements from the patient (clinical and therapeutic use), industry (production), and regulatory bodies (authorization process). This paper aims at reviewing the status and regulatory aspects of nano-based drug delivery systems with a focus on the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) regulations. In addition to discussing the risks accompanied by the development of nanomedicine, the potential of following a risk-based methodology from the early stage of the R&D phase is emphasized here to ensure safety and efficacy when developing novel nano-based dosage forms. The R&D of nanomedicines is a complex and multidisciplinary approach, and there are still many challenges in their regulation and legislation. In general, the most critical considerations for nanomedicines are the product quality assessment (physicochemical characteristics, quality control, manufacturing process) and product safety assessment (pharmacokinetics, biodegradation, accumulation, and nanotoxicity). The paper presents a promising paradigm in the development and marketing authorization of nanomedicines, namely the Quality by Design (QbD) approach. Sufficient knowledge on the quality, safety, and efficacy of nanomedicines is necessary to obtain a significant focus on establishing robust, standardized methods for evaluating the critical quality attributes of nanomedicines. The QbD-based submission is highly recommended and required by the regulatory authorities, enabling a smooth clinical translation of the novel nanomedicines.
Topics: Humans; Nanomedicine; Reproducibility of Results; United States
PubMed: 33823761
DOI: 10.2174/0929867328666210406115529 -
Therapeutic Innovation & Regulatory... Mar 2024This qualitative study aims to analyze current PM regulation and market access requirements and proposes potential solutions to mitigate current challenges.
OBJECTIVES
This qualitative study aims to analyze current PM regulation and market access requirements and proposes potential solutions to mitigate current challenges.
METHODS
Twenty-two semi-structured interviews were conducted with experts from pharmaceutical industry, regulatory authorities, national health technology assessment (HTA) bodies, pediatricians, and academia from the Netherlands (NL), Germany (DE), the United Kingdom (UK), and France (FR) to get insight into the pediatric research, the regulatory and reimbursement processes, challenges, and solutions. Themes for further testing were developed on how to facilitate pediatric market access. Atlas.ti 9 was used to analyze the findings.
RESULTS
Heterogeneity in requirements for the European Medicines Agency (EMA) and HTA approvals are noted. By example, DE grants direct reimbursement after regulatory approval, the other countries require additional reimbursement which generate delays and challenges in patient access after marketing authorization. Key components in facilitating PM market access include multi-stakeholder collaboration, transparency, patient representatives, informed consent guidance, real-world evidence, and appropriate clinical trial designs. Pricing models based on the economic capabilities of individual countries could further reduce delays and challenges in market access. The additional specific pediatric incentives should be taken as best practice to encourage innovation in pediatric conditions.
CONCLUSION
This study highlights differences in requirements for regulatory and reimbursement approval, along with international differences in pricing and reimbursement procedures for pediatric market access.
Topics: Child; Humans; Costs and Cost Analysis; Germany; United Kingdom; Qualitative Research
PubMed: 38172379
DOI: 10.1007/s43441-023-00601-6 -
Heliyon Jul 2023Cities in the global south, constrained by limited resources, face challenges in delivering efficient transportation infrastructure and services to support their rapidly... (Review)
Review
Cities in the global south, constrained by limited resources, face challenges in delivering efficient transportation infrastructure and services to support their rapidly growing urban populations. Dhaka, serves as an example, as it grapples with the increasing demand driven by population growth, exacerbated by factors like land and resource scarcity, as well as intricate geopolitical dynamics. Despite the construction of a metro rail and other similar mass transit options, Dhaka continues to face difficulties in meeting the increasing transportation demand, posing a persistent challenge. Multiple institutions, including a coordination authority, are working to provide improved transportation services by implementing diverse strategic approaches focusing on infrastructure development, and formulating policies aimed at facilitating better mobility and accessibility. Over the past fifty years, the institutional arrangement and roles within the transportation system have changed. This study examines the institutional arrangements and how they have evolved, along with reviewing transportation development policies during this period. The findings indicate the involvement of multiple organizations in the city's transportation system performing distinct activities-- administrative, coordinating, legislative, regulatory, construction and management, and law enforcement. These authorities often encounter challenges fulfilling their responsibilities stemming from differences in vision, organizational structure, jurisdiction and most notably, lack of coordinatoon, resulting in ineffective infrastructure development and duplicated activities. To improve the transportation system, this study recommends better equipping the existing coordinating authority and expanding its jurisdiction to include other institutions. This approach aims to enhance coordination and address the challenges faced by Dhaka's transportation system, ultimately facilitating improved mobility and accessibility for the city's growing population.
PubMed: 37456001
DOI: 10.1016/j.heliyon.2023.e17887 -
Journal of Environmental and Public... 2022Patients require accurate and reliable information to help them use their medications safely and effectively. Inadequate patient knowledge may contribute to medication...
BACKGROUND
Patients require accurate and reliable information to help them use their medications safely and effectively. Inadequate patient knowledge may contribute to medication nonadherence which could negatively affect treatment outcomes. The purpose of this study was to evaluate the presentation and completeness of medication package inserts (MPIs) which are available in the Ethiopian market.
METHODS
A cross-sectional document review was performed in February and March of 2019. All MPIs which were authorized by EFDA to sell in the Ethiopian market and available during the data collection period were considered.
RESULTS
The mean overall completeness score of 200 MPIs was 18.39 ± 4.30. Of the 200 MPIs, only 20% were from domestic pharmaceutical companies. Antimicrobials represented 24% of the total MPIs. Topical preparations, cardiovascular drugs, gastrointestinal drugs, and nonsteroidal anti-inflammatory drugs, accounted for 12.5%,12.5%, 11%, and 9% of the MPIs, respectively. The majority of the MPIs presented information about the drug's use during pregnancy and lactation, 77.0% and 74.0%, respectively. However, only half of the MPIs, 49.5%, gave information about special warnings and precautions. Only a few of the MPIs provided information about instructions to convert tablets or capsules into liquid forms and the possibility of tablet splitting, 4.8% and 8.7%, respectively. Furthermore, only 1.0% had local language translation.
CONCLUSION
The MPIs available in Ethiopia provide inadequate information including about the safety of drug products and local language translation. Regulatory authorities should implement stringent regulations to ensure the provision of vital information which extends beyond checking the mere presence of an MPI. They should also act to the possible standardization of MPIs.
Topics: Cross-Sectional Studies; Ethiopia; Female; Humans; Product Labeling
PubMed: 35096074
DOI: 10.1155/2022/8299218 -
Perspectives in Clinical Research 2023The regulatory approval process of the United States Food and Drug Administration and European Union is the most demanding and challenging worldwide. They have the... (Review)
Review
The regulatory approval process of the United States Food and Drug Administration and European Union is the most demanding and challenging worldwide. They have the provision of the expedited approval pathways, i.e., "Emergency use authorizations" and "Conditional marketing authorizations," respectively, to give approval to novel therapeutics agents during emergency situations. India, firstly formalized the accelerated pathway named "Accelerated Approval Process" as per the New Drugs and Clinical Trials rule 2019 to address unmet medical needs that was implemented by the Central Drug Standard Control Organization to approve the novel therapeutics agents during COVID-19. Hence, our aim is to understand and compare the different emergency approval processes in the world, their underlined claims and conditions with the list of approved products under this concept. All the information collected and analyzed from different official websites of regulatory bodies. In this review, we have enlightened on all these processes with their few approved products.
PubMed: 37325578
DOI: 10.4103/picr.picr_149_22 -
Emergency Medicine Australasia : EMA Jun 2023This research aimed to examine the legal and regulatory obligations of authorities and healthcare professionals in the provision of prison emergency health services and...
OBJECTIVE
This research aimed to examine the legal and regulatory obligations of authorities and healthcare professionals in the provision of prison emergency health services and to identify problems in the provision of emergency care to prisoners by using case examples from coronial findings.
METHODS
Review of legal and regulatory obligations and a search of coronial cases for deaths related to the provision of emergency healthcare in prisons in the past 10 years in Victoria, New South Wales and Queensland.
RESULTS
The case review identified several themes - issues with prison authority policies and procedures that delay access to timely healthcare or compromise the quality of care, operational and logistical factors, clinical issues and stigmatic issues including prison staff attitudes to prisoners requesting urgent healthcare assistance.
CONCLUSION
Coronial findings and royal commissions have repeatedly identified deficiencies in the emergency healthcare provided to prisoners in Australia. These deficiencies are operational, clinical and stigmatic and not limited to a single prison or jurisdiction. Applying a health quality of care framework focussed on prevention and chronic health management, appropriate assessment and escalation when urgent medical assistance is requested, and a structured audit framework could avoid future preventable deaths in prisons.
Topics: Humans; Prisoners; Prisons; Attitude of Health Personnel; New South Wales; Victoria
PubMed: 37009998
DOI: 10.1111/1742-6723.14205 -
Transnational Legal Theory 2022This article puts forward an approach to account for the evolution of transnational private rule-makers. Morphing of organisations, procedures, and rules is suggested as...
This article puts forward an approach to account for the evolution of transnational private rule-makers. Morphing of organisations, procedures, and rules is suggested as a key strength of various forms of private authority. Directing attention towards evolutionary dynamics, and their impact on the goals pursued by transnational private regulators, as well as on the implications for targets and beneficiaries of their rules, brings forward various implications of transnational private regulators. These implications include tensions between the complementary and competitive relations between public and private authority, and question the capacity of the former to effectively enrol, steer and influence the latter. The article discusses the role of regulatory and organisational crises as catalysts for the emergence and evolution of transnational private rule-makers, and how crises affect the relation between public and private regimes. Finally, we reflect on possible competitive challenges that emerge by employing a dynamic perspective to transnational private regulation.
PubMed: 36999165
DOI: 10.1080/20414005.2023.2178143 -
Advanced Healthcare Materials Dec 2023New and innovative nanomedicines have been developed and marketed over the past half-century, revolutionizing the prognosis of many human diseases. Although a univocal...
New and innovative nanomedicines have been developed and marketed over the past half-century, revolutionizing the prognosis of many human diseases. Although a univocal regulatory definition is not yet available worldwide, the term "nanomedicines" generally identifies medicinal products that use nanotechnology in their design or production. Due to the intrinsic high structural complexity of these products, the scientific and regulatory communities are reflecting on how to revise the regulatory framework to provide a more appropriate benefit/risk balance to authorize them on the market, considering the impact of their peculiar physicochemical features in the evaluation of efficacy and safety patterns. Herein, a critical perspective is provided on the current open issues regarding regulatory qualification and physicochemical characterization of nanosystems considering the current European regulatory framework on nanomedicine products. Practicable paths for improving their quality assurance and predicting their fate in vivo are also argued. Strengthening the multilevel alliance among academic institutions, industrial stakeholders, and regulatory authorities seems strategic to support innovation by standard approaches (e.g., qualification, characterization, risk assessment), and to expand current knowledge, also benefiting from the new opportunities offered by artificial intelligence and digitization in predictive modelling of the impact of nanomedicine characteristics on their fate in vivo.
Topics: Humans; Nanomedicine; Artificial Intelligence; Nanotechnology; Europe
PubMed: 37718353
DOI: 10.1002/adhm.202301956 -
Clinical Therapeutics Aug 2022For more than a decade, the World Health Organization, Pan American Health Organization, Pan-American Network or Drug Regulatory Harmonization, and the International... (Review)
Review
For more than a decade, the World Health Organization, Pan American Health Organization, Pan-American Network or Drug Regulatory Harmonization, and the International Conference of Drug Regulatory Authorities, have encouraged regulators to adopt reliance and recognition pathways to reduce duplication, improve efficiency and efficacy, and strengthen regulatory capabilities, in order to facilitate marketing authorization approval, thereby maintaining supply chain integrity. Several factors have limited the more widespread implementation of reliance pathways in Latin America, among which is having the appropriate legal tools in place between and among agencies. Key among these tools are the Memorandum of Understanding (MOU) and cooperation agreements. Herein we have reviewed the content and the characteristics of MOUs and cooperation agreements available on the official websites of the regulatory agencies of the region (we found 11 multilateral MOUs and 8 cooperation agreements published), signed by Latin American agencies and interregional organizations. In this commentary, common characteristics are identified and recommendations for further implementation are made to promote communication, information sharing, and trust, thereby supporting the broader use of reliance pathways in the region.
Topics: Humans; Latin America; Organizations; Pan American Health Organization
PubMed: 35798570
DOI: 10.1016/j.clinthera.2022.06.005